Thousands of heart patients who suffer from severe heart failure could benefit from a heart transplant. However, because of a shortage of donor hearts, most of these patients face a shortened life span characterized by frequent hospitalizations, severe physical disability, and death from congestive failure or cardiogenic shock.
One medical device developed to aid these heart patients is a heart pump such as a left ventricular assist device which enables heart failure patients to return to prolonged and productive lives. A left ventricular assist device (“LVAD”) is a battery-operated, mechanical pump-type device that is surgically implanted. It helps maintain the pumping ability of a heart that cannot effectively work on its own.
A LVAD typically includes an electrical cable which is hardwired into the LVAD and routed through a patient's body to an external controller and battery. The surgical procedure of creating a channel or “tunnel” for routing the electrical cable through the body is commonly called “tunneling.”
The “tunneling” procedure is an invasive procedure that can lead to infection. Therefore, to minimize the risk of infection and to provide a secure mechanical attachment between the electrical cable and the surrounding tissue, the tunneling channel or path is typically made smaller in size than the electrical connector attached at an end of the electrical cable. The electrical connector is the part of the electrical cable that plugs into or engages the external controller. Usually, the electrical connector is larger in size than the flexible body portion of the electrical cable. As a result, the force required to physically pull the electrical cable through a patient's body is relatively high.
The surgical procedures for creating a tunneling channel or path in a patient's body varies widely. In one procedure, commonly called the outside-in procedure, the tunneling path is created by a tunneling tool, which starts forming the tunnel on the outside of the patient's body. The tunnel goes through the abdominal cavity and up into the thoracic cavity near the LVAD and heart. After the tunnel or pathway is made in the patient's body, the electrical cable is tied to the tunneling tool by a suture or other means. The electrical cable is then dragged or pulled back through the tunneling path using the tunneling tool until a suitable length of the electrical cable extends from the patient's body to connect the electrical cable to the external controller.
In another procedure, commonly called the inside-out procedure, the tunneling path is started from the thoracic cavity inside of the patient's body and continues out through the patient's abdomen and skin to outside of the patient's body. The electrical cable is tied or otherwise connected to the end of the tunneling tool inside the body and pulled through the path to outside the body.
Both of the tunneling procedures described above and other similar procedures employ a relatively high force to pull or drag the electrical cable through the tunnel or path formed in the patient's body. The high stress on the tissues of the body cause trauma to the issues and could lead to complications, infection and extended recovery time for patients.
Additionally, depending on which procedure is used, the design of the tunneling tool may be suitable for one procedure such as the outside-in procedure, but not suitable or usable for another procedure, such as the inside-out procedure.
Accordingly, there is a need for a surgical tool which is adaptable to be used for different tunneling procedures, which is easy to manipulate and use during a tunneling procedure and which minimizes the stress on the body and the risk of infection during the procedure.